Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy
May 6, 2012 updated by: Mauro Maioli, Ospedale Misericordia e Dolce
Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography
Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure.
Hydration with sodium bicarbonate is more protective than isotonic saline in animals.
Limited data are available in humans.
We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Prato, Italy, 59100
- Ospedale Misericordia e Dolce
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with creatinine clearance < 60 mL/min
Exclusion Criteria:
- contrast medium administration within the previous 10 days
- end-stage renal failure requiring dialysis
- refusal to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Bicarbonate
|
Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure
|
|
Active Comparator: B
Saline
|
Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mauro Maioli, MD, Cardiology Unit - Prato
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
January 22, 2008
First Submitted That Met QC Criteria
January 22, 2008
First Posted (Estimate)
February 5, 2008
Study Record Updates
Last Update Posted (Estimate)
May 8, 2012
Last Update Submitted That Met QC Criteria
May 6, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prato0701
- POCARD0701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.